Clinical TrialDepressive DisordersRecruiting

Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression

This randomised controlled trial (n=45) evaluates a 55-minute psychedelic-like VR intervention (Psyrreal) versus a non-psychedelic VR analogue and a conditional waitlist in adults with clinical depression.

Target Enrollment
45 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

This interventional, randomised, double-blind parallel study uses immersive virtual reality to simulate psychedelic phenomenology (Psyrreal) and compare its effect on depressive symptoms with a non-psychedelic VR analogue (Routine Realms) and a possible waitlist condition.

Each experimental and comparator session is a single 55-minute immersive VR experience embedded in a therapeutic protocol with a preparatory session and a subsequent integration session. The trial will explore clinical outcomes and potential mediators to clarify the role of psychedelic-like subjective experience in treatment response.

Study Protocol

Preparation

1 sessions

Dosing

1 sessions
55 min each

Integration

1 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psyrreal

experimental

Psychedelic virtual reality experience.

Interventions

  • Compound
    via Other• single session• 1 doses total

    55-minute immersive psychedelic VR; part of therapeutic intervention with preparatory and integration sessions.

Routine Realms

active comparator

Non-psychedelic VR analogue.

Interventions

  • Compound
    via Other• single session• 1 doses total

    55-minute non-psychedelic immersive VR; part of therapeutic intervention with preparatory and integration sessions.

No intervention

waitlist

Conditional waiting list (may be included subject to resources).

Interventions

  • Compound

    No intervention; conditional waiting list.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Persistent depressive symptoms observed during the initial screening and confirmed at baseline, as determined through a comprehensive psychiatric evaluation.
  • Provision of written informed consent by the participant.
  • Fluent in Estonian as a native language.

Exclusion Criteria

  • Exclusion Criteria:
  • Significant impairments in vision, hearing, or balance.
  • Active suicidal ideation or current engagement in self-harm behaviours. Individuals meeting this criterion will be directed to suitable crisis intervention services.
  • Established diagnosis of bipolar disorder.
  • Manifestation of psychotic symptoms.
  • History of schizophrenia, either personally or within two generations of the family lineage.
  • Ongoing diagnosis of epilepsy, dementia, or any other neurological condition that could interfere with the effective utilisation of virtual reality (VR) technology.
  • Susceptibility to motion sickness.

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment45 participants
  • Timeline
    Start: 2023-11-06
    End: 2024-11-30
  • Topic
    Depressive Disorders

Locations

Confido Medical Centre — Tallinn, Harju, Estonia

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